Trial record 3 of 9 for:
retosiban
A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor (NEWBORN-1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02377466 |
Recruitment Status :
Terminated
(Asset terminated by PIB)
First Posted : March 3, 2015
Results First Posted : July 19, 2018
Last Update Posted : July 28, 2020
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Sponsor:
GlaxoSmithKline
Collaborator:
PPD
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Obstetric Labour, Premature |
Interventions |
Drug: Retosiban IV infusion Drug: Placebo IV infusion |
Enrollment | 25 |
Participant Flow
Recruitment Details | NEWBORN-1 was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to investigate efficacy and safety of retosiban in female participants aged 12 to 45 years with an uncomplicated singleton pregnancy in preterm labor with intact membranes between 24 0/7 and 33 6/7 weeks gestation. The study was conducted in 3 countries. |
Pre-assignment Details | Twenty-five participants were randomly assigned to study treatments: 12 participants to retosiban intravenous (IV) infusion and 13 participants to matched placebo IV infusion. Two participants randomized to retosiban arm did not receive study treatment. The study was terminated early due to feasibility of recruiting the study in a timely manner. |
Arm/Group Title | Placebo | Retosiban |
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Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. | Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. |
Period Title: Overall Study | ||
Started | 13 | 12 |
Treated | 13 | 10 |
Completed | 13 | 10 |
Not Completed | 0 | 2 |
Reason Not Completed | ||
Other: Randomized and not treated | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Placebo | Retosiban | Total | |
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Placebo was 0.9 percent sodium chloride infusion matched for retosiban volume, IV loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment. | Participants were administered 6 milligram (mg) IV loading dose of retosiban over 5 minutes followed by a 6 milligram per hour (mg/hour) continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg/hour continuous infusion for remainder of 48-hour treatment period. | Total of all reporting groups | |
Overall Number of Baseline Participants | 13 | 10 | 23 | |
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Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | 10 participants | 23 participants | |
26.5 (6.78) | 27.7 (6.73) | 27.0 (6.63) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | 10 participants | 23 participants | |
Female |
13 100.0%
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10 100.0%
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23 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 13 participants | 10 participants | 23 participants |
African American/African Heritage |
2 15.4%
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2 20.0%
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4 17.4%
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Asian-Central/South Asian Heritage |
0 0.0%
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1 10.0%
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1 4.3%
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Asian-East Asian Heritage |
1 7.7%
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0 0.0%
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1 4.3%
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Asian-Japanese Heritage |
4 30.8%
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2 20.0%
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6 26.1%
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Asian-South East Asian Heritage |
1 7.7%
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0 0.0%
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1 4.3%
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White-White/Caucasian/European Heritage |
5 38.5%
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5 50.0%
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10 43.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02377466 |
Other Study ID Numbers: |
200719 2014-003326-41 ( EudraCT Number ) |
First Submitted: | February 26, 2015 |
First Posted: | March 3, 2015 |
Results First Submitted: | January 22, 2018 |
Results First Posted: | July 19, 2018 |
Last Update Posted: | July 28, 2020 |